Technical Specialist and Scheme Manager

3 weeks ago


Chaoyang Qu, China BSI Full time

Are you a Microbiologist or Sterilization Engineer looking for a new challenge?

BSI is seeking a highly skilled Technical Specialist and Scheme Manager (Microbiology) to join our team.

Key Responsibilities:

• Conduct audits of clients' management systems to ensure compliance with regulatory and voluntary requirements.

• Perform comprehensive medical device reviews, including sterilization validation.

• Make recommendations on whether to issue a certificate based on objective evidence of device safety and effectiveness.

Requirements:

• Minimum 4 years' experience as a microbiologist and/or sterilization engineer for a sterile medical device manufacturer.

• Bachelor's degree in Microbiology, Biology, or related scientific field.

• Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR).

• Quality management experience, including participation in third-party quality audits.

Language Requirements:

• Native Mandarin speaking required for China-based role.

• Native Japanese speaking required for Japan-based role.

Our Values:

Client-centric, Agile, Collaborative. These values represent how we do things at BSI.

BSI is committed to conducting face-to-face interviews where possible. If you prefer a virtual interview, please speak to a member of our recruitment team.



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